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復星醫藥：海外監管公告 - 關於控股子公司獲藥品臨床試驗批准的公告

FOSUN PHARMA: An announcement has just been published by the issuer in the Chinese section of this website, a corresponding version of which may or may not be published in this section

Hong Kong Stock Exchange ·  Apr 17 05:43
Summary by Moomoo AI
上海復星醫藥（集團）股份有限公司（簡稱「復星醫藥」）宣布其控股子公司上海復宏漢霖生物技術股份有限公司及其控股子公司（合稱「復宏漢霖」）近日獲得國家藥品監督管理局批准，同意開展一項針對局部晚期或轉移性肝細胞癌（HCC）的新藥聯合治療方案的II期臨床試驗。該治療方案包括自主研發的HLX53（抗TIGIT的Fc融合蛋白）與汉斯状®（斯魯利單抗注射液）和汉贝泰®（貝伐珠單抗注射液）的聯合使用。復星醫藥表示，該聯合治療方案在全球範圍內尚無同類聯合用藥治療方案獲批上市，並且該公司對於該治療方案至今已投入約人民幣122萬元的研發資金。公司提醒投資者，新藥研發至上市存在諸多不確定因素，並存在一定風險，包括临床试验可能因安全性和/或有效性等問題而終止。公告日期為2024年4月17日。
上海復星醫藥（集團）股份有限公司（簡稱「復星醫藥」）宣布其控股子公司上海復宏漢霖生物技術股份有限公司及其控股子公司（合稱「復宏漢霖」）近日獲得國家藥品監督管理局批准，同意開展一項針對局部晚期或轉移性肝細胞癌（HCC）的新藥聯合治療方案的II期臨床試驗。該治療方案包括自主研發的HLX53（抗TIGIT的Fc融合蛋白）與汉斯状®（斯魯利單抗注射液）和汉贝泰®（貝伐珠單抗注射液）的聯合使用。復星醫藥表示，該聯合治療方案在全球範圍內尚無同類聯合用藥治療方案獲批上市，並且該公司對於該治療方案至今已投入約人民幣122萬元的研發資金。公司提醒投資者，新藥研發至上市存在諸多不確定因素，並存在一定風險，包括临床试验可能因安全性和/或有效性等問題而終止。公告日期為2024年4月17日。
SHANGHAI FUSTAR PHARMACEUTICALS (GROUP) CO., LTD. (“FUSTAR PHARMACEUTICALS”) ANNOUNCES THAT ITS HOLDING COMPANY SHANGHAI FUHUNG HANLIN BIOTECHNOLOGY CO., LTD. AND ITS HOLDING SUBSIDIARIES (COLLECTIVELY, “FUFUNG HANLIN”) HAVE RECENTLY RECEIVED APPROVAL FROM THE NATIONAL MEDICINES REGULATORY AUTHORITY, AGREEING TO INITIATE A PROJECT AIMED AT THE LOCAL LATE STAGE Or Phase II clinical trial of a new drug combination therapy solution for metastatic hepatocellular cancer (HCC). The treatment plan involves the combined use of HLX53 (Fc fusion protein against TIGIT), which was developed autonomously, with Hans® (anti-Srulline injection) and Hambet® (Beaverl single anti-injection solution). FUSTAR PHARMACEUTICALS SAID THAT THE COMBINED TREATMENT PLAN HAS NOT YET BEEN APPROVED GLOBALLY AND THAT THE COMPANY HAS INVESTED ABOUT RMB122 MILLION IN R&D FUNDING FOR THE TREATMENT TO DATE. THE COMPANY REMINDS INVESTORS THAT THERE ARE MANY UNCERTAINTIES IN THE DEVELOPMENT OF NEW DRUGS TO MARKET AND CERTAIN RISKS, INCLUDING THAT CLINICAL TRIALS MAY BE TERMINATED DUE TO SAFETY AND/OR EFFICACY ISSUES. The announcement date is 17 April 2024.
SHANGHAI FUSTAR PHARMACEUTICALS (GROUP) CO., LTD. (“FUSTAR PHARMACEUTICALS”) ANNOUNCES THAT ITS HOLDING COMPANY SHANGHAI FUHUNG HANLIN BIOTECHNOLOGY CO., LTD. AND ITS HOLDING SUBSIDIARIES (COLLECTIVELY, “FUFUNG HANLIN”) HAVE RECENTLY RECEIVED APPROVAL FROM THE NATIONAL MEDICINES REGULATORY AUTHORITY, AGREEING TO INITIATE A PROJECT AIMED AT THE LOCAL LATE STAGE Or Phase II clinical trial of a new drug combination therapy solution for metastatic hepatocellular cancer (HCC). The treatment plan involves the combined use of HLX53 (Fc fusion protein against TIGIT), which was developed autonomously, with Hans® (anti-Srulline injection) and Hambet® (Beaverl single anti-injection solution). FUSTAR PHARMACEUTICALS SAID THAT THE COMBINED TREATMENT PLAN HAS NOT YET BEEN APPROVED GLOBALLY AND THAT THE COMPANY HAS INVESTED ABOUT RMB122 MILLION IN R&D FUNDING FOR THE TREATMENT TO DATE. THE COMPANY REMINDS INVESTORS THAT THERE ARE MANY UNCERTAINTIES IN THE DEVELOPMENT OF NEW DRUGS TO MARKET AND CERTAIN RISKS, INCLUDING THAT CLINICAL TRIALS MAY BE TERMINATED DUE TO SAFETY AND/OR EFFICACY ISSUES. The announcement date is 17 April 2024.
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